Skip to main content
OpenTrials
Completed

NCT Number: NCT05369962

Adverse Event Prediction in Geriatric Patients in the ED With Ultrasound

The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Frailty Adverse Event Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMCG

Groningen, Netherlands

About this study

Background:

Older people visit the Emergency Department (ED) more frequently then younger people and have a higher risk of functional decline, ED revisit or death. Several screening tools (such as the Dutch safety management system (VMS) and Acutely Presenting Older Patient (APOP)) have been developed to identify patients at the highest risk of adverse outcomes. Almost all require adequate communication with the patient, which is not always possible, for example when elderly patients present with a delirium. Point of Care Ultrasonography (POCUS) may be a valuable alternative screening tool in these instances.

Main research question:

To identify whether POCUS measurement of the rectus femoris muscle cross-sectional area (Qcsa) can be used as an alternative screening tool to predict functional decline, ED revisit or death in elderly patients in the ED.

Design (including population, confounders/outcomes):

This is a single centre prospective trial. Patients >70 years and older presenting in the ED of the University Medical Centre Groningen (UMCG) who are participating in the Acutelines bio-databank are eligible for inclusion. 68 patients will be included. Data will be extracted from the Acutelines bio-databank. A trained physician will perform ultrasound measurements in a standardized way.

Expected results:

The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age (>70 years)
  • Presenting to the ED of the UMCG for one of the following specialties: internal medicine, nephrology, geriatric medicine, oncology, hematology, lung medicine, gastrointestinal/liver medicine, or emergency medicine (non-trauma).
  • Consent obtained for participation in the Acutelines bio-databank

Exclusion criteria

  • Unable to obtain ultrasound image of rectus femoris (e.g. amputation, edema)
  • Paresis or paralysis of one or both legs

Treatment and study plan

Ultrasound

Device

Ultrasound measurements of the Qcsa

Primary outcomes

  1. Ultrasound Qcsa

    Time frame: 1 day of admission to ED

    POCUS Qcsa in older patients in the ED.

  2. ED revisit

    Time frame: 3 months

    Is there a relation between the performed POCUS Qcsa measurement at ED visit and ED revisit in older patients.

  3. Mortality

    Time frame: 3 months

    Is there a relation between the performed POCUS Qcsa measurement at ED visit and mortality in older patients.

Secondary outcomes

  1. ED revisit: Ultrasound Qcsa versus Karnofsky Performance Score

    Time frame: 3 months

    To compare the ability of the Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict ED revisit in older patients in the ED.

  2. Mortality: Ultrasound Qcsa versus Karnofsky Performance Score

    Time frame: 3 months

    To compare the ability of the Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict mortality in older patients in the ED.

  3. ED revisit: Ultrasound Qcsa plus Karnofsky Performance Score

    Time frame: 3 months

    To compare the added value of Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict ED revisit in older patients in the ED.

  4. Mortality: Ultrasound Qcsa plus Karnofsky Performance Score

    Time frame: 3 months

    To compare the added value of Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict mortality in older patients in the ED.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: AGEDU

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 11, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.